Understanding the EU TPD, or How To Plait Sawdust!

Please note that Flavour Concentrates will not be restricted by the regulations.Only products containing Nicotine on our website will be affected.

The TPD (Tobacco Products Directive) fiasco has been going on for a considerable time, but now we are close to the implementation date when it will be passed into UK law.The arguments have raged on and on, but we just want to inform our customers how the new regulations will affect their vaping lifestyle.

The main points are:

1) The maximum strength of Nicotine liquids will be limited to 2% (20mg/ml).2) The maximum size of refill bottles containing Nicotine liquid will be 10ml.3) The maximum capacity of any tank/clearomiser etc will be 2ml.4) There will be a transition period between May 20th 2016 and May 20th 2017.

All of the above will have to be tested and notified to the EU in order to gain an EC ID number which will allow them to be sold.Below this brief explanation is the Guidance page from the MHRA (Medicines & Healthcare products Regulatory Agency) which isthe organisation responsible for implementing the regulations in the UK. Below that is a copy of Section 6 of the statutory instrumentwhich was laid before Parliament and which forms the new UK regulations.It's easy to see just how much bureaucracy and expensive testing of products will be involved in order to keep products on the marketand/or to introduce new products.

Transition Period.

Products falling under TPD Regulations on sale before May 20th 2016 must be notified by November 20th 2016. If they are not notified,Retailers will be allowed to sell off existing stock until May 20th 2017, but only if it was produced prior to November 20th 2016.Any products that have not been notified must then be withdrawn from sale on May 20th 2017.

So, the products containing Nicotine, including the larger than 10ml sizes, will remain on sale through to May 20th 2017.

Supplies of higher strength Nicotine liquid (higher than 2% {20mg/ml}) will inevitably begin to run down leading up to May 20th 2017,as will supplies of Nicotine liquid in bottles with a capacity greater than 10ml; that is of course, unless changes which are being calledfor not just by manufacturers/retailers/vapers, but by members of the House of Lords, are introduced.

Overview

The Tobacco Products Directive 2014/14/EU (TPD) introduces new rules for nicotine-containing e-cigarettes and refill containers (Article 20). MHRA is responsible for implementing the majority of provisions under Article 20 and has been designated as the competent authority for the notification scheme for e-cigarettes and refill containers in the UK.

The TPD introduces new rules which ensure:

minimum standards for the safety and quality of all e-cigarettes and refill containers (otherwise known as e-liquids)

that information will be provided to consumers so that they can make informed choices

an environment that protects children from starting to use these products

The UK Tobacco and Related Products Regulations 2016, which were laid before Parliament on 22 April 2016, implement the TPD in the UK, and come into force on 20 May 2016. Part 6 of the regulations sets out the requirements for e-cigarettes and refill containers.

From May 2016, the regulations introduce requirements for producers of e-cigarettes and refill containers. A producer is anyone who manufactures or imports these products or who re-brands any product as their own. Producers must submit information about their products to MHRA through a European Common Entry Gate (EU-CEG) notification portal.

If the manufacturer has submitted a UK notification for the specific product you import, then you do not need to submit a duplicate notification. Similarly, if the manufacturer has notified details of a product that you have re-branded, and your brand name is listed in the manufacturer’s notification, then you do not need to submit a duplicate notification.

Retailers do not need to submit information for any products they sell unless they also qualify as a producer. Retailers have until 20 May 2017 to sell through stock of products that do not comply with the labelling and product composition requirements of the TPD.

When MHRA is satisfied that a product notification is complete and complies with the TPD, we will publish all non-confidential information. Producers will be able to specify information that they consider to be confidential when they submit a notification.

The TPD does not cover nicotine-containing products that are authorised as medicines.

Putting a new product into the UK market

From 20 May 2016 onwards, producers of new e-cigarette and refill container products will need to submit a notification to MHRA 6 months before they intend to put their product on the UK market.

There are transitional arrangements for the period between 20 May to 19 November 2016. During this period, applications for new products which companies intend to put on the market must be made at least one day before they are sold for the first time.

A product which has been substantially modified will count as a new product and must also follow this process. Further information regarding what qualifies as a substantial modification can be found in the guidance on submission type below.

Products already in the UK market

Producers of all e-cigarettes and refill containers that are covered by the TPD and are on the market before 20 May 2016 will have until 20 November 2016 to submit a notification to MHRA. After that date producers may only sell batches of a product that does not comply with the TPD requirements if the batch was produced before 20 November 2016.

Advice for retailers

If you sell e-cigarettes and / or e-liquids by retail to the general public, you need to be aware of the transition periods for implementation of the new rules:

20 May 2016 – 19 November 2016

No change.

20 November 2016 – 19 May 2017

You may continue to sell products you already have in stock during this period.

When sourcing new supplies of any e-cigarette or e-liquid product, ask your supplier whether the product complies with the requirements of the TPD. If the answer is no, be aware that you may only sell the product until 19 May 2017.

On 20 May 2017

You will need to remove from sale any remaining stocks of products that do not comply with the TPD.

From 20 May 2017

When sourcing new supplies of any e-cigarette or e-liquid product, check that details of the notification for the product have been published on the MHRA website. A link will be made available here when the web page goes live.

If you cannot find the product on the MHRA website, ask your supplier to confirm that the product complies with the TPD and has been notified to MHRA. If a producer has not notified the product or it does not comply with the TPD, they may not supply it to you.

Are you also a producer?

As a retailer, you do not need to notify any products you sell unless you are also a ‘producer’ of the product.

A producer is anyone who manufactures or imports e-cigarette or e-liquid products and anyone who re-brands them as their own. If you qualify as a producer, please see the transition period guidance for producers above.

If you import or re-brand products, check with your supplier whether they have already made a UK notification for the specific product you sell. If they have done so, you do not need to submit a duplicate notification.

Cross Border Sales

From 20 May 2016, you need to register your business if you supply e-cigarette products via cross-border distance sales, for example online sales.

This applies to:

businesses established in the UK selling e-cigarettes and / or e-liquids to consumers in another EEA state (European Economic Area – the 28 EU Member States plus Iceland, Liechtenstein and Norway)

businesses established in the EEA or third country selling to UK consumers.

Business to business sales, that is sales not direct to consumers, do not need to be registered.

Registration is a legal requirement under the TPD. Without confirmation of registration businesses must not supply a relevant product to a consumer via a cross-border distance sale.

We are publishing below initial draft guidance to aid producers of e-cigarettes and e-liquids to prepare notifications for their products. This guidance has been developed by the UK and other member states and discussed at the European Commission Working Group on notification of e-cigarettes and refill containers.

The TPD does not include any requirements as to where testing of e-cigarettes and refill container has to take place. The notifier will need to be satisfied as to the standards of any testing carried out as they have to submit a declaration that they bear full responsibility for the quality and safety of the product when placed on the market and used under normal or reasonably foreseeable conditions.

MHRA has given a commitment to review the level of fees in the light of the number of notifications received in the first year.

Labeling your product

Regulation 37 of the Tobacco and Related Products Regulations 2016 sets out the requirements for labelling of e-cigarette and e-liquid products. Additional advice on labelling or e-liquid products is available here - Labeling Guidance (PDF, 85.2KB, 2 pages)

Reporting problems with e-cigarette products

Problems with e-cigarettes or refill containers should be reported to the producer. Consumers can also contact Citizens Advice to report any problems.

From 20 May 2016, producers should inform MHRA if they have reason to believe that a notifiable product is unsafe, not of good quality or not compliant with TPD regulations and provide details of the risk to human health and safety and any corrective action taken.

Further details on how to report problems with e-cigarettes to MHRA will be published here when the TPD comes into force.

Key terms

The definitions of products that are subject to the new regulations are set out below.

‘Electronic cigarette’ means a product that can be used for consumption of nicotine-containing vapour via a mouth piece, or any component of that product, including a cartridge, a tank and the device without cartridge or tank. E-cigarettes can be disposable or refillable by means of a refill container and a tank, or rechargeable with single use cartridges.

Products that require a notification are limited to the e-cigarette product and component elements sold separately that specifically contain, or could contain, nicotine in the form of e-liquid. Therefore products such as disposable units and tanks will require a notification; however equipment such as mouthpieces, batteries and other elements that would qualify as an individual component will not.

‘Refill container’ means a receptacle that holds a nicotine-containing liquid, which can be used to refill an electronic cigarette. These are more commonly known as e-liquids.

Products that do not meet the definition (such as disposable e-cigarettes that do not contain nicotine and 0% nicotine e-liquids) are out of scope of the TPD and do not have to meet its requirements. These products will continue to be regulated under the General Product Safety Regulations.

‘Producers’ refers to any manufacturer; importer and/or those who re-brand any of the products covered by the above definitions as their own.

Statutory Instruments2016 No. 507

Consumer ProtectionThe Tobacco and Related Products Regulations 2016

Made

18th April 2016

Laid before Parliament

22nd April 2016

Coming into force

20th May 2016

The Secretary of State makes these Regulations in exercise of the powers conferred by section 2(2) of the European Communities Act 197

PART 6Electronic cigarettesNotification about electronic cigarettes and refill containers

31.—(1) A producer who supplies or intends to supply electronic cigarettes or refill containers must notify the Secretary of State in accordance with this regulation.

(2) Where an electronic cigarette or refill container is substantially modified (“a modified product”) a producer must comply with paragraph (1) in respect of the modified product.

(3) A notification under paragraph (1) must contain the following information (so far as relevant to the product concerned)—

(a)the name and contact details of the person who manufactures the product, the importer (if applicable) and, if neither is based in a member State, a responsible person within a member State;

(b)a list of all ingredients contained in, and emissions resulting from the use of, the product by brand and variant name, including quantities;

(c)toxicological data regarding the product’s ingredients (including in heated form) and emissions, referring in particular to their effects on the health of consumers when inhaled and taking into account, amongst other things, any addictive effect;

(d)information on the nicotine dose and uptake when consumed under normal or reasonably foreseeable conditions;

(e)a description of the components of the product including, where applicable, the opening and refill mechanism of the electronic cigarette or refill container;

(f)a description of the production process and a declaration that the production process ensures conformity with the requirements of this Part; and

(g)a declaration that the producer bears full responsibility for the quality and safety of the product when supplied and used under normal or reasonably foreseeable conditions.

(4) Paragraph (1) does not apply to an importer in respect of a product if—

(a)another producer has notified the Secretary of State in respect of that product; and

(b)the information submitted by that producer has been published in accordance with regulation 34(a).

(5) Paragraph (1) does not apply to a producer in respect of a product if the producer intends to withdraw the product from the market by 20th November 2016.

(6) Notification under paragraph (1) must be submitted in respect of a product—

(a)at least one day before the day the producer first supplies the product, where—

(i)a producer intends to first supply a product which is not a modified product during the period beginning with 20th May 2016 and ending with 19th November 2016 (“a new transitional product”), or

(ii)a producer intends to first supply a modified new transitional product during the period beginning with 20th May 2016 and ending with 19th November 2016;

(b)on or before 19th November 2016,where—

(i)a producer first supplied a product before 20th May 2016 (“an existing product”) and intends to continue to supply that product on or after 20th November 2016, or

(ii)a producer intends to first supply a modified existing product during the period beginning with 20th May 2016 and ending with 19th May 2017; or

(c)in any other case, at least six months before the date on which the producer intends to first supply a product or a modified product.

(7) Unless the Secretary of State directs otherwise, notification is not regarded as submitted for the purposes of paragraph (6) until any fee which may be payable in connection with the notification has been paid.

(8) A producer must notify the Secretary of State before, or as soon as reasonably practicable after, the producer withdraws a product that has been notified under paragraph (1) from the market.

(9) Paragraph (8) does not apply to an importer in respect of a product if another producer has notified the Secretary of State that the product has been withdrawn from the market.

(10) Where the Secretary of State considers that the information submitted under this regulation is incomplete, the Secretary of State may request the producer concerned to provide the complete information.

(11) A producer must comply with a request under paragraph (10) by the date reasonably required by the Secretary of State.Annual reporting requirement

32.—(1) A producer of electronic cigarettes or refill containers must submit the following information to the Secretary of State—

(a)comprehensive data on the producer’s sales volumes in the United Kingdom, by brand and variant name;

(b)any information available to the producer, whether published or not, on the preferences of consumer groups in the United Kingdom, including young people, non-smokers and the main types of current users;

(c)the mode of sale of the producer’s products in the United Kingdom; and

(d)executive summaries of any market surveys carried out by the producer in respect of paragraphs (a) to (c).

(2) The information listed in paragraph (1)(a) to (d) must be submitted annually on or before 20th May each year, and must relate to the preceding calendar year.

(3) The first submission under paragraph (2) is to be made on or before 20th May 2018 in respect of the calendar year 2017.

(4) The information listed in paragraph (1)(a) to (d) relating to the period beginning with 20th May 2016 and ending with 31st December 2016 must be submitted on or before 20th May 2017.

(5) The Secretary of State must monitor the market developments concerning electronic cigarettes and refill containers, including any evidence that their use is a gateway to nicotine addiction and ultimately traditional tobacco consumption amongst young people and non-smokers.Submission of information

33.—(1) This regulation applies to a person who notifies the Secretary of State under regulation 31 or submits any information under regulation 32.

(2) Information must be submitted to the Secretary of State—

(a)in electronic form;

(b)by means of the entry gate for data submission referred to in Article 2.2 of Commission Implementing Decision (EU) 2015/2183 of 24 November 2015 establishing a common format for the notification of electronic cigarettes and refill containers(1);

(c)in accordance with the administrative requirements set out in that Decision; and

(d)in the format specified in the Annex to that Decision.

(3) A person submitting information under regulation 31 must specify any information which that person considers to constitute a trade secret.Secretary of State duty to publish notifications etc.

34. The Secretary of State must—

(a)ensure that information submitted under regulation 31 is made publicly available on a website, taking the need to protect trade secrets duly into account;

(b)provide the European Commission and the competent authorities of other member States with access to information submitted in accordance with any provision of this Part on request, ensuring that trade secrets are treated in a confidential manner.No supply of product where notification not complied with

35. A producer who is required to submit a notification under regulation 31(1) in respect of any electronic cigarettes or refill containers but fails to do so in accordance with that regulation and regulation 33 may not supply those electronic cigarettes or refill containers until—

(a)the producer has submitted the information listed in regulation 31(3) in respect of that product to the Secretary of State in accordance with regulation 33;

(b)the producer has paid any fee payable in connection with notification; and

(c)the information submitted by that producer has been published in accordance with regulation 34(a).Product requirements

36.—(1) No person may produce or supply an electronic cigarette or refill container unless it complies with paragraphs (2) to (8), so far as relevant to the product concerned.

(2) Nicotine-containing liquid which is presented for retail sale must be in—

(a)a dedicated refill container in a volume not exceeding 10 millilitres; or

(b)a disposable electronic cigarette, a single use cartridge, or a tank, in a volume not exceeding 2 millilitres.

(3) The capacity of the tank of a refillable electronic cigarette must not exceed 2 millilitres.

(4) Nicotine-containing liquid which is presented for retail sale in an electronic cigarette or refill container must not contain nicotine in excess of 20 milligrams per millilitre.

(5) Nicotine-containing liquid in an electronic cigarette or refill container—

(a)must not contain any additive referred to in regulation 16 (no vitamins, colourings or prohibited additives in tobacco products);

(b)must be manufactured using only ingredients of high purity;

(c)must not contain substances other than the ingredients notified under regulation 31, unless present in trace levels, where such trace levels are technically unavoidable during manufacture; and

(d)must not include ingredients (except for nicotine) which pose a risk to human health in heated or unheated form.

(6) An electronic cigarette must be able to deliver a dose of nicotine at consistent levels under normal conditions of use.

(7) An electronic cigarette or refill container must be—

(a)child-resistant and tamper-evident; and

(b)protected against breakage and leakage.

(8) An electronic cigarette or refill container must have a mechanism for ensuring re-filling without leakage (unless it is a disposable electronic cigarette).

(9) For the purposes of paragraph (7), a product is tamper-evident if it has one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence that the product (or its packaging) has been opened.

(10) For the purposes of paragraph (8), a product has a mechanism for ensuring re-filling without leakage if the mechanism—

(a)entails—

(i)the use of a refill container possessing a securely attached nozzle at least 9 millimetres long which is narrower than, and slots comfortably into, the opening of the tank of the electronic cigarette, and

(ii)in the case of refill containers, a flow control mechanism that emits no more than 20 drops of refill liquid per minute when placed vertically and subjected only to atmospheric pressure at a temperature between 15 and 25 degrees Celsius; or

(b)operates by means of a docking system which only releases refill liquids into the tank of an electronic cigarette when the electronic cigarette and refill container are connected.Product information and labelling requirements

37.—(1) No person may produce or supply an electronic cigarette or refill container unless it complies with paragraphs (2) to (6).

(2) Each unit packet of the electronic cigarette or refill container must include a leaflet with information on—

(a)instructions for use and storage of the product, including a reference that the product is not recommended for use by young people and non-smokers;

(b)contra-indications;

(c)warnings for specific risk groups;

(d)possible adverse effects;

(e)addictiveness and toxicity;

(f)contact details of the producer; and

(g)if the producer is not based in a member State, a contact person within a member State.

(3) Each unit packet and any container pack must include—

(a)a list of all ingredients contained in the product set out in descending order by weight;

(b)an indication of the nicotine content of the product and the delivery per dose;

(c)the batch number; and

(d)a recommendation to keep the product out of reach of children.

(4) Each unit packet and any container pack must carry a health warning consisting of the text: “This product contains nicotine which is a highly addictive substance”.

(5) The health warning must—

(a)appear on both the front and back surfaces of the unit packet and any container pack;

(b)cover 30% of the area of each of those surfaces, calculated in relation to the area of the surface concerned when the pack is closed;

(c)be in black Helvetica bold type on a white background;

(d)be in a font size which ensures that the text occupies the greatest possible proportion of the surface area reserved for it; and

(e)appear at the centre of that area.

(6) The health warning must be parallel to the main text on the surface concerned.

(7) For the purposes of paragraph (2)(a), the instructions for use must—

(a)include appropriate instructions for refilling, including diagrams; and

(b)comply with paragraph (8).

(8) Instructions for use comply with this paragraph where—

(a)if the refill mechanism is as described in regulation 36(10)(a), the instructions for use indicate the width of the nozzle or the width of the opening of the tank (as appropriate) in a manner that enables consumers to identify the compatibility of refill containers and electronic cigarettes; or

(b)if the refill mechanism is as described in regulation 36(10)(b), the instructions for use specify the type or types of docking system with which the electronic cigarette or refill container is compatible.

(9) Paragraph (7) does not apply to instructions for use that relate to disposable electronic cigarettes.Product presentation requirement

38.—(1) No person may produce or supply an electronic cigarette or refill container unless it complies with paragraphs (2) to (4).

(2) The unit packet and any container pack of the electronic cigarette or refill container may not include any element or feature falling within paragraph (3).

(3) An element or feature falls within this paragraph if it—

(a)promotes an electronic cigarette or refill container, or encourages its consumption by creating an erroneous impression about its characteristics, health effects, risks or emissions;

(b)suggests that a particular electronic cigarette or refill container—

(i)is less harmful than other electronic cigarettes or refill containers,

(c)refers to taste, smell or other additives (except flavourings) or the absence of any such thing;

(d)resembles a food or a cosmetic product; or

(e)suggests that a particular electronic cigarette or refill container has improved biodegradability or other environmental advantages.

(4) The unit pack or container pack in which an electronic cigarette or refill container is, or is intended to be, presented for retail sale may not contain any element or feature which suggests economic advantage by including printed vouchers or offering discounts, free distribution, two-for-one or other similar offers.

(5) The elements and features referred to in paragraphs (2) to (4) include (but are not limited to) text, symbols, names, trademarks, figurative or other types of sign.Vigilance requirements

39.—(1) A producer of electronic cigarettes or refill containers must establish and maintain a system for collecting information about all of the suspected adverse effects on human health of the product.

(2) Paragraphs (3) and (4) apply where a producer of electronic cigarettes or refill containers considers or has reason to believe that an electronic cigarette or refill container which is in its possession and is intended to be supplied, or which has been supplied, is not—

(a)safe;

(b)of good quality; or

(c)in conformity with this Part of the Regulations.

(3) The producer must (as appropriate)—

(a)immediately take the corrective action necessary to bring the product into conformity with this Part of the Regulations;

(b)withdraw the product;

(c)recall the product.

(4) The producer must immediately inform the Secretary of State and the competent authority of any other member State in which the product has been supplied or is intended to be supplied, giving details of, in particular—

(a)the risk to human health and safety;

(b)any corrective action taken; and

(c)the results of any corrective action taken.

(5) The Secretary of State or the competent authority of any other member State may request additional information from a producer of electronic cigarettes or refill containers, including information on the safety and quality aspects or any adverse effects of electronic cigarettes or refill containers.

(6) A producer must comply with a request made of it under paragraph (5) by the date reasonably required by the Secretary of State.Action to protect human health

40.—(1) This regulation applies where the Secretary of State has reasonable grounds to believe that an electronic cigarette or refill container, or a type of electronic cigarette or refill container, could present a serious risk to human health.

(2) The Secretary of State may take appropriate provisional measures to address the risk to human health.

(3) The measures that the Secretary of State may take include, but are not limited to—

(a)prohibiting the supply of the electronic cigarette or refill container, or the type of electronic cigarette or refill container;

(b)requiring each supplier of the electronic cigarette or refill container, or the type of electronic cigarette or refill container, to recall the product.

(4) The Secretary of State may take appropriate follow-up measures to implement any conclusions of the European Commission in relation to the matter.

(5) Any producer or supplier of a product that is the subject of a provisional measure or a follow-up measure must comply with the measure insofar as it applies to that producer or supplier.

If you got this far, well done and thank you, for now you realise just what manufacturers, producers, retailers are up against.Many small businesses will face closure which is a travesty; we might clear a few cowboys off the scene but at the cost of losingsome of the amazing innovators, designers, and mixologists who have helped to pioneer and drive development in our industry.They will be replaced by an oppressive set of regulations which will encourage Black Market trade and dubious imports.